Ignite Creation Date:
2025-12-25 @ 5:09 AM
Ignite Modification Date:
2025-12-26 @ 4:13 AM
Study NCT ID:
NCT04339127
Status:
UNKNOWN
Last Update Posted:
2020-04-09
First Post:
2020-04-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Autoimmune Encephalitis With Anti-NMDA Receptor Antibodies Following Herpetic Encephalitis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020274', 'term': 'Autoimmune Diseases of the Nervous System'}, {'id': 'D060426', 'term': 'Anti-N-Methyl-D-Aspartate Receptor Encephalitis'}, {'id': 'D020803', 'term': 'Encephalitis, Herpes Simplex'}], 'ancestors': [{'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D020361', 'term': 'Paraneoplastic Syndromes, Nervous System'}, {'id': 'D009423', 'term': 'Nervous System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D010257', 'term': 'Paraneoplastic Syndromes'}, {'id': 'D004660', 'term': 'Encephalitis'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}, {'id': 'D000090862', 'term': 'Neuroinflammatory Diseases'}, {'id': 'D018792', 'term': 'Encephalitis, Viral'}, {'id': 'D020805', 'term': 'Central Nervous System Viral Diseases'}, {'id': 'D002494', 'term': 'Central Nervous System Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D000069544', 'term': 'Infectious Encephalitis'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D006566', 'term': 'Herpesviridae Infections'}, {'id': 'D004266', 'term': 'DNA Virus Infections'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 12}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-04', 'completionDateStruct': {'date': '2020-10-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-04-06', 'studyFirstSubmitDate': '2020-04-06', 'studyFirstSubmitQcDate': '2020-04-06', 'lastUpdatePostDateStruct': {'date': '2020-04-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-04-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-06-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Details of clinical, biological, imaging, therapeutic characteristics and patient's evolution.", 'timeFrame': 'at 6 and 12 months', 'description': 'Retrospective collection of clinical, diagnostic and therapeutic data, evolution at 6 and 12 months.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Autoimmune Encephalitis', 'Anti NMDA Receptor Encephalitis', 'Herpetic Encephalitis']}, 'descriptionModule': {'briefSummary': 'Herpes Simplex Virus encephalitis is the most common infectious encephalitis, with an estimated annual incidence of 1 / 250,000 to 1 / 500,000 in industrialized countries. Despite a widely used antiviral treatment, the prognosis remains poor with a mortality of 5 to 20% and a considerable morbidity rate.\n\nOne of the contributing factors of bad prognosis is the development of encephalitis mediated by autoantibodies, most often directed against NMDA receptors, in the weeks following viral encephalitis.\n\nThe description of this pathology is recent, the pathophysiology of this process remains poorly understood, and the management of these patients is not yet codified.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '12 patients diagnosed between January 2014 and January 2020', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Clinical autoimmune encephalitis with anti-NMDA antibodies and documented by CBA in the CSF\n* After a herpetic encephalitis documented by a positive viral PCR for HSV in the CSF\n* Without age limit\n\nExclusion Criteria- No respect of inclusion criteria'}, 'identificationModule': {'nctId': 'NCT04339127', 'acronym': 'NMDARE-HSE', 'briefTitle': 'Autoimmune Encephalitis With Anti-NMDA Receptor Antibodies Following Herpetic Encephalitis', 'organization': {'class': 'OTHER', 'fullName': 'Hospices Civils de Lyon'}, 'officialTitle': 'Study of 12 Cases of Autoimmune Encephalitis With Anti-NMDA Receptor Antibodies Following Herpetic Encephalitis and Review of the Literature', 'orgStudyIdInfo': {'id': 'NMDARE-HSE'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Cohort NMDARE-HSE', 'description': 'Patients developing clinical autoimmune encephalitis with anti-NMDA antibodies after a herpetic encephalitis, managed by the National Reference Center for Paraneoplastic Syndromes and Autoimmune Encephalitis at the Neurological Hospital of Bron.', 'interventionNames': ['Other: Description and analysis']}], 'interventions': [{'name': 'Description and analysis', 'type': 'OTHER', 'description': 'Retrospective, non-interventional study, using clinical, biological, radiological and therapeutic data collected during the initial diagnosis and follow-up.', 'armGroupLabels': ['Cohort NMDARE-HSE']}]}, 'contactsLocationsModule': {'locations': [{'zip': '69500,', 'city': 'Bron', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'JEROME HONNORAT, PhD', 'role': 'CONTACT', 'email': 'jejerome.honnorat@chu-lyon.fr', 'phone': '04 72 35 78 06'}], 'facility': 'Hospice Civils de Lyon', 'geoPoint': {'lat': 45.73865, 'lon': 4.91303}}], 'centralContacts': [{'name': 'Jérôme Honnorat, PhD', 'role': 'CONTACT', 'email': 'jerome.honnorat@chu-lyon.fr', 'phone': '04 72 35 78 06'}, {'name': 'Géraldine PICARD', 'role': 'CONTACT', 'email': 'geraldine.picard@chu-lyon.fr', 'phone': '0472355842'}], 'overallOfficials': [{'name': 'Jérôme Honnorat', 'role': 'STUDY_DIRECTOR', 'affiliation': 'National Reference Center of autoimmune encephalitis'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospices Civils de Lyon', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}